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European Commission: Public consultation of the revised chapter 5 of the GMP laying down the detailed guidelines for production

29.12.2010
This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. Reasons for changes: changes have been proposed to sections 25 and 26 on the qualification of suppliers of starting material in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. Supply chain traceability for starting materials is also introduced in sections 26 and 27. A new section, 31, is proposed in order to clarify and harmonise expectations of manufacturers regarding the testing of starting materials. Further work on chapter 5 is ongoing, affecting section 19, as referred to in the Concept Papers published by EMA in February 2005. EMA also published progress reports on this work in February 2008 and December 2009.